Promoting Clinical Research and Clinical Trials Online

Guidance note

Who is this note for?

Any member of staff considering publishing information online relating to Clinical Research or Clinical trials. †

1. Introduction

Any health-related research project which involves humans, their tissue and/or data must have been reviewed and be in receipt of a favourable opinion from a recognised Research Ethics Committee (REC) and the Joint Research Compliance Office (JRCO). Any experimental drug trials will also require authorisation from the regulatory authority – the Medicines and Healthcare products Regulatory Agency (MHRA) - prior to it commencing.

The Chief Investigator for a clinical trial or study is responsible for approving any materials, wording and formats used to promote the study or trial online and for ensuring all such materials and platforms used are in full compliance with the trial’s legal, contractual, research ethics approval and data protection requirements.

2. Before publishing online

You must ensure the trial has the requisite institutional, REC and MHRA approvals before developing any web or digital content, and ensure that:

You (and the Chief Investigator of the trial if that is not you) have read, understood and fully complied with all rules and requirements

A check has been made on whether there are any funder or other third party terms and conditions preventing publicity of any or all trial details. It is vital to be aware of any Confidentiality and any Intellectual Property provisions in such terms that might govern or limit your content.

Your College Department has assessed and approved your proposals for any required use of College equipment, hardware, digital platforms or networks for the management and communication of your trial (For FoM, contact the Departmental Manager in your Departmental Professional Support Team)

3. Best Practice for communicating about your Clinical Study or Trial

Plan how you want to communicate about your trial well ahead of submitting your ethics approval:

Research and agree which platforms, media, formats and wording you may wish to use for the recruitment, advertisement and communication of your trial for the lifetime of the project.

Check that these proposals will comply with statutory, legal, funder and institutional requirements

If you are not the Chief Investigator for your trial, you must obtain the approval of the Chief Investigator for the exact wording, formatting and platforms used before proceeding with development.

If the Chief Investigator has any queries or concerns, he/she may seek guidance from the JRCO.

Include details of all of your proposals, and exact wording of your advertisement materials within your application for ethics approval

If, after receipt of ethics approval, you realise you would like to use a particular format or set of wording which was not included and approved within your original ethics approval, you should approach the JRCO for advice on whether an amendment to the ethics application may be required.

4. How to submit a request for College facilities and support to promote your trial online

Ensure all required actions and approvals are in place (see 2 above) and include confirmation of this with your request. (Note: it is not the responsibility of ICT or your Faculty/Dept. Web Officer to obtain/check approvals).

If you intend to use only standard College-provided web tools and formats for your communications, contact your Departmental Web Officer for help

If your request involves the use of a non-Imperial web address or setting up of an internal hosted (ie. Imperial owned servers) dedicated website you will need to submit a request through the College Web Exception process.

† Important note:This guidance note relates to communication about clinical research activities, which are relevant to the College’s academic mission. It should be noted that the processing of data for patient management purposes is not permitted on the College network or equipment connectedto it and such material must not be included within College websites or digital media.